| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00875197005936 | 07972466190 | 07972466190 | cobas Zika (480 tests) | ||||
| 2 | 00365702398108 | 5530199160 | 5530199160 | GJS | TEST, TIME, PROTHROMBIN | 2 | CoaguChek XS Pro Kit | |
| 3 | 00075537180075 | 11379194160 | 11379194160 | KHE | REAGENT, OCCULT BLOOD | 2 | Calibration Strip (Urisys 1100, cobas u 411) | |
| 4 | 00075537018934 | 11893467160 | 11893467160 | CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | 1 | Chemstrip 5 OB Test Strips | |
| 5 | 07613336215845 | 08836973160 | 08836973160 | Elecsys HIV Duo | MZF | Test, HIV detection | 2 | Elecsys HIV Duo |
| 6 | 07613336184615 | 09038078160 | 09038078160 | Vitamin D total G3 Elecsys cobas e 100 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
| 7 | 07613336179512 | 09205683001 | 09205683001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro transport line | |
| 8 | 07613336179499 | 09205632001 | 09205632001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro SSU | |
| 9 | 07613336172650 | 09038086190 | 09038086190 | Vitamin D total G3 Elecsys E2G 300 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
| 10 | 07613336171677 | 09007784190 | 09007784190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
| 11 | 07613336171660 | 09007741190 | 09007741190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
| 12 | 07613336170212 | 08924180160 | 08924180160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
| 13 | 07613336170182 | 08924163160 | 08924163160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
| 14 | 07613336166949 | 08836973190 | 08836973190 | MZF | Test, HIV detection | 2 | Elecsys HIV Duo | |
| 15 | 07613336164884 | 08764760190 | 08764760190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
| 16 | 07613336159804 | 04985354160 | 04985354160 | Anti-HBs CC 3 Elecsys | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | Anti-HBs CalCheck |
| 17 | 07613336158784 | 08463662001 | 08463662001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas c 503 analytical unit | |
| 18 | 07613336155332 | 08372284001 | 08372284001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
| 19 | 07613336155318 | 08376824190 | 08376824190 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
| 20 | 07613336154403 | 03500373190 | 03500373190 | MTG | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Ca Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | 3 | free PSA CalCheck | |
| 21 | 07613336154373 | 04491734160 | 04491734160 | tPSA reagent 200 | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
| 22 | 07613336154366 | 04641655160 | 04641655160 | tPSA reagent, 100 Test-Kit | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
| 23 | 07613336154311 | 06427405160 | 06427405160 | Anti-HCV II 200-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
| 24 | 07613336154304 | 06368921160 | 06368921160 | Anti-HCV II 100-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
| 25 | 07613336153949 | 04927931161 | 04927931161 | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | PreciControl Anti-HBc II | |
| 26 | 07613336147672 | 08243875190 | 08243875190 | JIT | Calibrator, secondary | 2 | CalSet PTH | |
| 27 | 07613336141953 | 5920353001 | 5984840001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
| 28 | 07613336133644 | 08105596190 | 08105596190 | NDY | TEST, CYSTATIN C | 2 | Tina-quant Cystatin C Gen.2 | |
| 29 | 07613336133583 | 08105529190 | 08105529190 | JZG | System, test, beta-2-microglobulin immunological | 2 | Tinaquant ß2Microglobulin | |
| 30 | 07613336133521 | 08105448190 | 08105448190 | DER | ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Apolipoprotein A-1 ver.2 | |
| 31 | 07613336130230 | 08101396190 | 08101396190 | DEM | ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant a1-Antitrypsin ver.2 | |
| 32 | 07613336121429 | 08058024190 | 08058024190 | JIF | ENZYMATIC METHOD, AMMONIA | 1 | Ammonia II | |
| 33 | 07613336121351 | 08057940190 | 08057940190 | KHP | ACID, LACTIC, ENZYMATIC METHOD | 1 | Lactate Gen.2 | |
| 34 | 07613336121238 | 08057648190 | 08057648190 | DBF | FERRITIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Ferritin Gen.4 | |
| 35 | 07613336121108 | 08057435190 | 08057435190 | KLT | ENZYME IMMUNOASSAY, CARBAMAZEPINE | 2 | ONLINE TDM Carbamazepine Gen.4 | |
| 36 | 07613336121061 | 08056951190 | 08056951190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Bilirubin Direct Gen.2 | |
| 37 | 04015630999477 | 5133181160 | 5133181160 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Elecsys Anti-CCP CalCheck | |
| 38 | 04015630995318 | 11776827160 | 11776827160 | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | Elecsys CalCheck FSH | |
| 39 | 04015630999200 | 4357221190 | 4357221190 | DLJ | CALIBRATORS, DRUG SPECIFIC | 2 | Total MPA Calibrators | |
| 40 | 04015630999149 | 4924495190 | 4924495190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
| 41 | 04015630997954 | 4642465190 | 4642465190 | LEG | ENZYME IMMUNOASSAY, VALPROIC ACID | 2 | Valproic Acid ONLINE TDM Valproic Acid | |
| 42 | 04015630997756 | 4490894190 | 4490894190 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
| 43 | 04015630996575 | 3304680190 | 3304680190 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | Preciset DAT Plus II | |
| 44 | 04015630995202 | 11776614190 | 11776614190 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | AFP CalCheck | |
| 45 | 04015630994847 | 11815601216 | 11815601216 | LGI | FLUORESCENCE POLARIZATION IMMUNOASSAY, CARBAMAZEPINE | 2 | CEDIA Carbamazepine II | |
| 46 | 04015630994533 | 20766356122 | 20766356122 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | LSD CalibrationControl Pack | |
| 47 | 04015630993468 | 20737976122 | 20737976122 | DIS | ENZYME IMMUNOASSAY, BARBITURATE | 2 | Abuscreen OnLine Barbiturates | |
| 48 | 04015630993284 | 11986082216 | 11986082216 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
| 49 | 04015630991853 | 11876899216 | 11876899216 | CFR | HEXOKINASE, GLUCOSE | 2 | Glucoquant GlucoseHK | |
| 50 | 04015630991778 | 11868152190 | 11868152190 | DML | NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD | 2 | Ethyl Alcohol ETH |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 09120052071351 | 30220141 00 | 30220141 | This media contains V 7.4 of the following registered Medical Devices:(DI)091200 This media contains V 7.4 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X) | USB-STICK MAGELLAN PRO V7.4 | TECAN AUSTRIA GMBH |
| 2 | 09120052071238 | 30204301 00 | 30204301 | This media contains V 7.3 of the following registered Medical Devices:(DI)091200 This media contains V 7.3 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X) | USB-STICK MAGELLAN PRO V 7.5 | TECAN AUSTRIA GMBH |
| 3 | 09120052071092 | 30185384 00 | 30185384 | This media contains V 7.4 of the following registered Medical Devices:(DI)091200 This media contains V 7.4 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X) | USB-STICK MAGELLAN PRO V7.4 | TECAN AUSTRIA GMBH |
| 4 | 09120052071023 | 30182624 00 | 30182624 | This media contains the following registered Medical Devices:(DI) 09120052070996 This media contains the following registered Medical Devices:(DI) 09120052070996 MAGELLAN V7.X(DI) 09120052071009 MAGELLAN TRACKER V7.X | USB-STICK MAGELLAN 7.3 SP2 | TECAN AUSTRIA GMBH |
| 5 | 09120052071009 | MAGELLAN TRACKER V7.X | 30183890 | Reader control and data reduction software for Tecan Microplate Reader. | MAGELLAN | TECAN AUSTRIA GMBH |
| 6 | 09120052070996 | MAGELLAN V7.X | 30183889 | Reader control and data reduction software for Tecan Microplate Reader. | MAGELLAN | TECAN AUSTRIA GMBH |
| 7 | 09120052070941 | 30141795 00 | 30141795 | This media contains V 7.3 of the following registered Medical Devices:(DI)091200 This media contains V 7.3 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X) | USB-STICK MAGELLAN PRO V 7.3 | TECAN AUSTRIA GMBH |
| 8 | 09120052070910 | MAGELLAN PRO TRACKER V 7.X | Reader control and data reduction software for Tecan Microplate Reader. | MAGELLAN PRO | TECAN AUSTRIA GMBH | |
| 9 | 09120052070880 | MAGELLAN PRO V 7.X | Reader control and data reduction software for Tecan Microplate Reader. | MAGELLAN PRO | TECAN AUSTRIA GMBH | |
| 10 | 07640172343012 | PTB | ProTube is designed to automate biological sample collection process. ProTube en ProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. ProTube is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers, sample check-out and monitoring of transport parameters. | ProTube | INPECO SA | |
| 11 | 07640172343005 | PTB | The ProTube System is designed to automate biological sample collection process. The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out. | ProTube | INPECO SA | |
| 12 | 07613336177129 | 09180443001 | 09180443001 | cobas® infinity central lab | ROCHE DIAGNOSTICS GMBH | |
| 13 | 07613336164846 | 08763640001 | 08763640001 | cobas pro B-Gate update Kit | ROCHE DIAGNOSTICS GMBH | |
| 14 | 07613336164280 | 08739170001 | 08739170001 | cobas infinity POC IT solutions | ROCHE DIAGNOSTICS GMBH | |
| 15 | 07613336157046 | 08420254001 | 08420254001 | cobas infinity POC remote access | ROCHE DIAGNOSTICS GMBH | |
| 16 | 07613336156520 | 08368449001 | 08368449001 | BCM for cobas 8100 | ROCHE DIAGNOSTICS GMBH | |
| 17 | 07613327568998 | 0794111090 | 0794-111-090 | QBL Software License | N/A | STRYKER CORPORATION |
| 18 | 07613327568981 | 0694-002-100 | 0694-002-100 | + EMR/QBL APPLICATION | SURGICOUNT | STRYKER CORPORATION |
| 19 | 07311091391681 | 139168 | 139168 | HemoCue® 801 Connect | HemoCue® 801 Connect | HEMOCUE AB |
| 20 | 06438147352401 | 5002-0540 | 5002-0540 | The MSMS Workstation is intended for use as a calculator/data processing softwar The MSMS Workstation is intended for use as a calculator/data processing software for the storage, retrieval, and processing of mass spectrometry data. | MSMS Workstation | WALLAC OY |
| 21 | 06438147320905 | 5002-0500 | 5002-0500 | Specimen Gate® Screening Center™ is intended to be used for data management of n Specimen Gate® Screening Center™ is intended to be used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. | Screening Center | WALLAC OY |
| 22 | 06438147153312 | 5002-0180 | 5002-0180 | Specimen Gate® Laboratory is a modular laboratory information management system Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories. | Specimen Gate Laboratory | WALLAC OY |
| 23 | 06438147153275 | 5002-0130 | 5002-0130 | Specimen Gate® PatientCare™ is intended for management of the follow-up workflow Specimen Gate® PatientCare™ is intended for management of the follow-up workflow of a screening system. | PatientCare | WALLAC OY |
| 24 | 05700574037314 | K5810AA | Bench LAB CNV | Bench Lab CNV | AGILENT TECHNOLOGIES BELGIUM | |
| 25 | 05700574035631 | K5849AA | Alissa Interpret | Alissa Interpret | AGILENT TECHNOLOGIES BELGIUM | |
| 26 | 05415062388310 | CI4054279 | Software to identify heart failure patients who may be at risk of having wtATTR-CM | wtATTR-CM AcceleraTTR™ | PFIZER INC. | |
| 27 | 04048534002011 | 0760-0101 | 0760-0101 | EKF Link is a data and device management system that enables healthcare professi EKF Link is a data and device management system that enables healthcare professionals to transfer, manage, store and display measurement results from point -of-care diagnostic testing analyzers. EKF Link enables the allocation of additional information to measurement results and facilitates the export or transfer of data for documentation purposes.EKF Link is intended to be used as an optional software application with EKF point -of-care analyzers and open to be interfaced to other vendor’s point-of-care testing analyzers verified for connection with EKF Link.EKF Link facilitates the setting of configurable options of connected analyzers. | EKF Link | EKF-DIAGNOSTIC GMBH |
| 28 | 04015630942305 | 06884750001 | 06884750001 | B-Gate Interface | ROCHE DIAGNOSTICS GMBH | |
| 29 | 04015630936007 | 07154003001 | 07154003001 | cobas® infinity central lab | ROCHE DIAGNOSTICS GMBH | |
| 30 | 04015630929078 | 05349966001 | 05349966001 | cobas p 701 Post-Analytical Unit | ROCHE DIAGNOSTICS GMBH | |
| 31 | 04015630929061 | 05158494001 | 05158494001 | cobas p 501 post-analytical unit | ROCHE DIAGNOSTICS GMBH | |
| 32 | 04015630035342 | 04420306001 | 04420306001 | cobas IT 1000 | ROCHE DIAGNOSTICS GMBH | |
| 33 | 03770027519041 | TD-Web | TD-Web is a web solution to easily manage orders creation, optimize collection TD-Web is a web solution to easily manage orders creation, optimize collection management and provide real-time results access at the patient’s bedside. | TD-Web | TECHNIDATA | |
| 34 | 03770027519034 | TDWorkstation | TDWorkstation is a powerful software designed to interface instruments with any TDWorkstation is a powerful software designed to interface instruments with any Laboratory Information System (LIS) and manage results with efficiency and flexibility. | TDWorkstation | TECHNIDATA | |
| 35 | 03770027519010 | TDHisto/Cyto | TDHisto/Cyto is a software used for managing medical information in the field TDHisto/Cyto is a software used for managing medical information in the field of laboratories performing histology, non-gynecological and gynecological cytology and autopsy activities.. | TDHisto/Cyto | TECHNIDATA | |
| 36 | 03770027519003 | TDNexLabs | TDNexLabs is a Laboratory Information System (LIS) (software product) intended t TDNexLabs is a Laboratory Information System (LIS) (software product) intended to be used for the management of clinical information.TDNexLabs is intended to be used only by health professionals. | TDNexLabs | TECHNIDATA | |
| 37 | 00883489001450 | GP200 | Rightest | BIONIME CORPORATION | ||
| 38 | 00883489000873 | GP200 | GE | BIONIME CORPORATION | ||
| 39 | 00862696000289 | 0 | a calculator/data processing module for clinical use described as electronic dev a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data. | BG Analytics Software | ASSOCIATES OF CAPE COD, INC. | |
| 40 | 00859519002247 | DMS | The Telserve® Data Management System is an accessory to blood glucose monitoring The Telserve® Data Management System is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. | Telserve® Data Management System | TELCARE, LLC | |
| 41 | 00859474006397 | 1.0.6.2 | SoftTotalQC | SCC SOFT COMPUTER | ||
| 42 | 00859474006861 | 3.5.52.0 | SoftMolecular | SCC SOFT COMPUTER | ||
| 43 | 00859474006854 | 3.5.52.0 | SoftHLA | SCC SOFT COMPUTER | ||
| 44 | 00859474006847 | 3.5.52.0 | SoftFlowCytometry | SCC SOFT COMPUTER | ||
| 45 | 00859474006830 | 3.5.52.0 | SoftPathDx | SCC SOFT COMPUTER | ||
| 46 | 00859474006823 | 3.5.52.0 | SoftCytogenetics | SCC SOFT COMPUTER | ||
| 47 | 00859474006816 | 3.5.52.0 | SoftBiochemistry | SCC SOFT COMPUTER | ||
| 48 | 00859474006632 | 4.5.5.51 | SoftLab | SCC SOFT COMPUTER | ||
| 49 | 00859474006625 | 4.5.5.51 | SoftMic | SCC SOFT COMPUTER | ||
| 50 | 00859474006618 | 4.5.5.51 | SoftROE | SCC SOFT COMPUTER |